Competitive Problems in the Drug Industry, Volume 4; Volume 6U.S. Government Printing Office, 1968 |
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Page 1220
... labeling . The content of package - insert type of labeling is initially approved by FDA during the new - drug clearance procedure and is constantly reviewed by our medical staff to insure that the labeling is consistent with current ...
... labeling . The content of package - insert type of labeling is initially approved by FDA during the new - drug clearance procedure and is constantly reviewed by our medical staff to insure that the labeling is consistent with current ...
Page 1222
... labeling . The best pos- sible outcome as far as I am concerned , would be for PMA to exercise leadership in this area , assume the burden and use , if such could be arranged , the format of the PDR , if the owners of PDR were willing ...
... labeling . The best pos- sible outcome as far as I am concerned , would be for PMA to exercise leadership in this area , assume the burden and use , if such could be arranged , the format of the PDR , if the owners of PDR were willing ...
Page 1224
... labeling bearing such information in the labeling authorized by the approved new - drug application or required as a condition for the certification or the exemption from certification requirements applicable to preparations of insulin ...
... labeling bearing such information in the labeling authorized by the approved new - drug application or required as a condition for the certification or the exemption from certification requirements applicable to preparations of insulin ...
Page 1225
... labeling , and we re- view it . And if we find flaws there , we then direct the firms to take remedial action . Senator NELSON . But you do not review it prior to publication ? Dr. GODDARD . I do not think we should . I think the burden ...
... labeling , and we re- view it . And if we find flaws there , we then direct the firms to take remedial action . Senator NELSON . But you do not review it prior to publication ? Dr. GODDARD . I do not think we should . I think the burden ...
Page 1227
... labeling is the basis of new drug approval , we recommend that such labeling be retained , and additionally , the pack- age insert type of information should remain available for persons , such as clinical researchers , who are in need ...
... labeling is the basis of new drug approval , we recommend that such labeling be retained , and additionally , the pack- age insert type of information should remain available for persons , such as clinical researchers , who are in need ...
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Common terms and phrases
addiction advertising APPLE arrests atropine sulfate brand name CALLAHAN cardiologist Chairman clinical codeine committee communications compendium Contergan contraindications cost DEAR DOCTOR developed diphenoxylate discuss dispensing dosage dose Drug Administration Drug Application drug products electrocardiograms firms Food and Drug formulary GODDARD going GORDON GROSSMAN hearings hospital hydrochlorothiazide industry labeling laboratory letter Lomotil malformations marihuana medical center medicine MEYER narcotics package insert patient percent pharmacist pharmacy phocomelia physician practice prednisone pregnancy prescribing prescription drugs present problem profession professional question reaction Reader's Digest record referred reported Searle Company Senator HATFIELD Senator JAVITS Senator NELSON side effects statement STEEVES STETLER studies subcommittee tablets talking tape TAUSSIG telephone teletypewriter testimony tests thalidomide therapeutic therapy tion toxicity United United States Attorney USP standards Wisconsin
Popular passages
Page 1262 - Labeling on or within the package from which the drug is to be dispensed bears adequate information for its use, including indications, effects, dosages, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions...
Page 1460 - Because of the high potency of the drug and the variability of its potential to cause adverse reactions, the following are strongly recommended: 1) the lowest possible effective dose for the individual patient should be prescribed. Increased dosage tends to increase adverse...
Page 1320 - Therefore, corrective action involving deceptive practices in the sale of furniture would be initiated under the Authority of section 5 of the Federal Trade Commission Act which prohibits "unfair methods of competition in commerce, and unfair or deceptive acts or practices in commerce.
Page 1529 - Department of Pediatrics, The Johns Hopkins University School of Medicine and the...
Page 1446 - This summary shall fairly show the effectiveness of the drug in the conditions for which it is recommended in the advertisement, together with a showing of those side effects and contraindications that are pertinent with respect to the uses recommended or suggested in the advertisement and any other use or uses for which the dosage form advertised is commonly prescribed.
Page 1438 - You are therefore hereby commanded, to attach the said above-entitled article and to detain the same in your custody until the further order of the Court respecting the same, and to give due notice to all persons claiming the same, or knowing or having anything to say why the same should not be condemned...
Page 1441 - That all and singular the premises are true, and within the admiralty and maritime jurisdiction of the United States and of this honorable court.
Page 1262 - Upon written request, stating reasonable grounds therefor, the Commissioner will offer an opinion on a proposal to omit such information from the dispensing package...
Page 1269 - My examination was made in accordance with generally accepted auditing standards, and accordingly included such tests of the accounting records and such other auditing procedures as I considered necessary in the circumstances. In my opinion, the accompanying combined statements of assets, liabilities and...
Page 1438 - Court issue in this behalf, and that all persons interested in the before-mentioned and described schooner or vessel may be cited in general and special to answer the premises, and all due proceedings being had, that the said...